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. 2019 Nov;8(Suppl 3):S235–S246. doi: 10.21037/tlcr.2019.04.20

Table 6. Prospective randomized phase III studies of first-generation EGFR TKIs in untreated patients with advanced EGFR mutation-positive NSCLC.

Study Population Treatment arms No. of pts RR (%) Median PFS Median OS
Months HR; P Months HR; P
IPASS East Asian Gefitinib 609 [132]* 43.0 (71.2) 9.5 0.48; <0.001 21.6 1.0; 0.99
Adeno & nonsmokers Carbo/pacli 608 [129]* 32.2 (47.3) 6.3 21.9
First- Korean Gefitinib 159 [26]* 55.4 (84.6) 8.4 0.544; 0.086 22.3 0.932; 0.60
SIGNAL Adeno & nonsmokers Cis/gem 150 [16]* 46.0 (37.5) 6.7 22.9
WJTOG3405 Japanese Gefitinib 86 62.1 9.2 0.489; <0.0001 35.5 1.2; 0.44
EGFR mut Cis/doce 86 32.2 6.3 38.8
NEJ002 Japanese Gefitinib 114 73.7 10.8 0.30; <0.001 27.7 0.88; 0.48
EGFR mut Carbo/pacli 114 30.7 5.4 26.6
OPTIMAL Chinese Erlotinib 82 83 13.1 0.16; <0.0001 22.8 1.19; 0.26
EGFR mut Carbo/gem 72 36 4.6 27.2
EURTAC European Erlotinib 86 64 9.7 0.37; <0.0001 19.3 1.04; 0.87
EGFR mut Platinum CT 87 18 5.2 19.5
ENSURE Asian Erlotinib 110 62.7 11 0.34; <0.0001 26.3 0.91; 0.61
EGFR mut Cis/gem 107 33.6 5.5 25.5

*, patients with confirmed EGFR mut. EGFR, epidermal growth factor receptor; TKIs, tyrosine-kinase inhibitors; NSCLC, non-small cell lung cancer.